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Title: Desloratadine Reduces Patient-Rated Symptoms of Intermittent Allergic Rhinitis: Presented at EAACI

"Desloratadine Reduces Patient-Rated Symptoms of Intermittent Allergic Rhinitis: Presented at EAACI"

By Chris Berrie BARCELONA, Spain -- June 10, 2008 -- Desloratadine significantly reduces individual symptom scores and total symptom scores in patients with intermittent allergic rhinitis, according to results of a randomised controlled study. Investigator Richard Lorber, MD, Schering-Plough Corporation, Kennilworth, New Jersey, presented the study findings here on June 8 at the 27th Congress of the European Academy of Allergology and Clinical Immunology (EAACI). According to Dr. Lorber, the Allergic Rhinitis and Its Impact on Asthma (ARIA) guidelines reclassified allergic rhinitis as intermittent and persistent allergic rhinitis rather than the traditional seasonal and perennial allergic rhinitis. "[As opposed to] being based on the allergen, it is based on the duration of symptoms," he explained. For their study, Dr. Lorber and colleagues defined intermittent allergic rhinitis as presence of allergic rhinitis symptoms for less than 4 days per week or less than 4 consecutive weeks per year. He said that this study is the first prospective, placebo-controlled desloratadine intervention performed with patients who have ARIA-defined intermittent allergic rhinitis. A total of 547 patients over the age of 12 years were randomised to placebo (n = 271) or desloratadine 5 mg once daily (n = 276) for 15 days. All patients had a positive skin-prick test to at least 1 relevant allergen(s) and at least a 2-year history of ARIA-defined intermittent allergic rhinitis. All subjects experienced symptomatic disease at screening, using a 12-hour reflective 5-symptom total symptom scale (T5SS) that measured nasal congestion/stuffiness, sneezing, rhinorrhoea/nasal discharge, nasal pruritus, and ocular pruritus. These scores were graded according to a 4-point severity score (0 = absence, 3 = severe). For inclusion in the study, the subject's total T5SS score needed to be at least 6. Patients rated and recorded in study diaries their morning and evening symptoms for current (NOW) and previous 12-hour (PRIOR) severities. The primary endpoint was change from baseline (day 1) of mean PRIOR total T5SS scores to the final assessment (day 15). Ratings of treated patients of the PRIOR severities all demonstrated improvements for desloratadine compared with placebo over the 15-day period, as follows: nasal congestion/stuffiness (-0.56 vs -0.43; [P = .013); sneezing (-0.64 vs -0.42; P < .021); rhinorrhoea/nasal discharge (-0.58 vs -0.38; P < .021); nasal pruritus (-0.67 vs -0.43; P < .021); and ocular pruritus (-0.57 vs -0.46; nonsignificant).

These improvements were all apparent from day 1 (P < .033; eye pruritis, nonsignificant). Significant improvements were also seen for days 2 to 15 in the NOW individual T5SS scores (P < .03), as from day 2 (P < .03).

At baseline, the placebo and desloratadine groups showed similar PRIOR total T5SS scores of 8.33 and 8.50, respectively. For the primary endpoint, there was a significant improvement in the treatment group over the placebo group (-3.01 vs -2.13). This improvement was significant from day 1 (P < .001) and was maintained over the 15 days (P < .013).

For days 2 to 15, the NOW total T5SS scores also showed a significant benefit in the desloratadine group compared with the placebo group (-2.66 vs -1.83). This improvement was significant as early as day 2 (P < .001) and averaged over days 2 to 15 (P < .001).

Desloratadine was well tolerated, with treatment-related adverse events similar for placebo (7.0%) and desloratadine (7.2%). The most frequent adverse events were headache, fatigue, nausea, somnolence, and thirst. No serious adverse events were reported across either treatment group.

In concluding, Dr. Lorber noted, "[Desloratadine] is a very effective second-generation antihistamine in this type of rhinitis classification, based on the ARIA guidelines."

He added that desloratadine also showed very good efficacy for nasal decongestion, which generally is not considered to respond to antihistamines.

Dr. Lorber presented this study on behalf of the AERIUS Control: Clinical and Epidemiological Profile of Treatment (ACCEPT1) Study Group and the Global Allergy and Asthma European Network (GA²LEN).

Funding for this study was provided by Schering-Plough Corporation.

[Presentation title: Desloratadine Significantly Reduces Total Symptoms Scores in Subjects With Intermittent Allergic Rhinitis: Results of the ACCEPT1 Study in Collaboration With GA²LEN. Abstract P1744]

[Presentation title: Desloratadine Significantly Reduces Nasal Congestion and Other Individual Symptoms Scores in Subjects With Intermittent Allergic Rhinitis: Results of the ACCEPT1 Study in Collaboration With GA²LEN. Abstract P1760]

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